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Transrectal Ultrasound Imaging of the Prostate Gland and Neurovascular Bundles During Robot-Assisted Laparoscopic Radical Prostatectomy

This study has been terminated.
(The number of participants needed for this study has been met.)
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00952666
First received: August 4, 2009
Last updated: September 10, 2010
Last verified: August 2009

August 4, 2009
September 10, 2010
November 2008
December 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00952666 on ClinicalTrials.gov Archive Site
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Not Provided
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Transrectal Ultrasound Imaging of the Prostate Gland and Neurovascular Bundles During Robot-Assisted Laparoscopic Radical Prostatectomy
Transrectal Ultrasound (TRUS) Imaging of the Prostate Gland and Neurovascular Bundles (NVB) During Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP)

Neurovascular bundle (NVB) contains capsular vessels to the prostate and cavernous nerves that provides the macroscopic landmark used during nerve-sparing radical prostatectomy. The preservation of NVB during radical prostatectomy improves postoperative recovery of potency and continence. However, the visualization of the NVB during radical prostatectomy can be challenging.

Recently, an attempt has been made to use a transrectal ultrasound (TRUS) imaging to delineate the anatomy of the prostate gland and NVB during laparoscopic radical prostatectomy. However, it is difficult to obtain a steady image of TRUS with an operator. The investigators plan to perform a feasibility study to obtain TRUS imaging of the prostate and NVB during robot-assisted laparoscopic radical prostatectomy (RALRP). The investigators plan to use a robot-assisted TRUS probe holder to gently manipulate the probe to obtain steady TRUS images that may aid in visualization and dissection of the NVB during RALRP.

During surgery for prostate cancer, precise resection of the tumor-containing prostate gland and preservation of the neurovascular bundle (NVB) are critical in preventing tumor recurrence and potency preservation following surgery. However, due to the periprostatic connective tissues and bleeding, it is difficult to visualize NVB during surgery, even with surgical loupes or laparoscopic magnification.

Ultrasound (US) is commonly used in imaging the prostate during diagnostic and therapeutic procedures such as diagnostic biopsy. US image in addition to the classic laparoscopic imaging can potentially provide decreased surgical margins and improve the dissection of the NVB during laparoscopic radical prostatectomy (LRP) according to the study by the Cleveland Clinic group. In their study, an assistant manipulated the TRUS probe under the direction of the surgeon and held it in place as requested. At critical points of the surgery, the surgeon visualized the NVB on the Doppler-capable ultrasound monitor. The images, however, were difficult to interpret because the surgeon was not in direct control of the TRUS probe. In addition, it was challenging for surgeon to communicate with the assistant to obtain steady and useful image. Moreover, their study was performed exclusively in LRP without the daVinci® robot (Intuitive Surgical, Inc.), more commonly performed surgical approach for radical prostatectomy.

To overcome these obstacles in the study by Ukimura and al., we propose to use a mechanical support arm for holding and manipulating the TRUS probe during the daVinci® robot-assisted laparoscopic radical prostatectomy (robotic LRP)..

This application is for a feasibility study involving six patients. We will obtain TRUS images of the prostate and NVB during a robotic LRP procedure. These images will be acquired in the first part of the operation and performed with minimal interference to the operation. We will record and analyze the TRUS images to investigate the feasibility of using mechanical support arm for the TRUS probe. The proposed study is a proof of concept for a following protocol.

Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Device: TRUS-RALRP
During surgery, and part of this research study, the ultrasound probe (TRUS) will be placed in the rectum. Then, using the mechanical support arm to hold and adjust the probe we will take ultrasound images during a portion of the robotic LRP surgery. The ultrasound probe will then be removed, and we will complete the LRP surgery as we usually do. We expect this to add approximately 20 minutes to the regular surgery time; the maximum added time will be 30 minutes.
Other Name: TRUS support arm with daVinci robot
Experimental: Device
Both the Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP) and the Transrectal Ultrasound (TRUS) are common performed procedures, but are normally performed separately. In this proposed feasibility study, the procedures will be combined.
Intervention: Device: TRUS-RALRP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for a Laparoscopic Radical Prostatectomy operation
  • Patients must be between the ages of 35 and 75
  • Patients must not have one of the above listed exclusion criteria
  • Patients must be able to understand and willing to adhere to the study protocol

Exclusion Criteria:

  • Patients less than 35 years of age and over 75 years of age
  • Patients with previous rectal surgery
  • Patients with anal stenosis that prevents the TRUS probe insertion
  • Patients with extensive abdominal surgery
  • Patients with inadequate bowel prep
  • Patients who are unwilling or unable to sign informed consent
  • Patients on anticoagulation medication (e.g., coumadin, lovenox, or heparin)
Male
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952666
NA_00014120
Yes
Misop Han, M.D., M.S., Johns Hopkins Medical Institutions
Johns Hopkins University
Not Provided
Principal Investigator: Misop Han, M.D., M.S. Johns Hopkins University
Johns Hopkins University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP